Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 53-72 are currently pending in the instant application. Applicants have canceled claims 1-52 and added new claims 53-72 in an amendment filed on November 22, 2024. Claims 53-72 are rejected in this Office Action.
I. Priority
The instant application is a CON of 18/197,414, filed on May 15, 2023 PAT 12,187,689 which is a CON of 17/461,512, filed on August 30, 2021 PAT 11,680,051 which is a CON of 16/755, 439, filed on April 10, 2020 PAT 11,136,300 which is a 371 of PCT/IB2018/057840, filed on October 10, 2018 and claims benefit of Foreign Application INDIA 201741036169, filed on October 11, 2017.
II. Information Disclosure Statement
The information disclosure statements (IDS) submitted on January 15, 2025 and March 11, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
III. Rejections
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 53-72 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 11,136,300. Although the conflicting claims are not identical, they are not patentably distinct from each other because:
Applicants claim
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212
775
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Determining the Scope and Content of the Issued Patent
Claims 1-25 of the issued patent claims
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158
280
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Greyscale
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287
287
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Greyscale
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569
292
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Ascertaining the Differences Between the Instant Application and the Issued Patent
The difference between the product of the instant claims and the issued patent’s product claims is that the instant product has to be a hydrate whereas does not have to be a hydrate.
Finding Prima Facie Obviousness
The X-ray diffraction peaks of the instant application is the same as the peaks claimed in the issued patent’s claims 5-9 and 11-15. Both crystalline forms have the same peaks and are prepared the same way according to the specification. Therefore, one of ordinary skill in the art would be motivated to prepare and claim both crystalline forms in the issued patent again in the instant application since majority of the peaks are the same. As a result, the claims are rejected under obviousness-type double patenting.
Claims 53-72 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,680,051. Although the conflicting claims are not identical, they are not patentably distinct from each other because:
Applicants claim
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212
775
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Greyscale
Determining the Scope and Content of the Issued Patent
Claims 1-25 of the issued patent claims
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268
284
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Greyscale
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815
676
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Greyscale
Ascertaining the Differences Between the Instant Application and the Issued Patent
The difference between the product of the instant claims and the issued patent’s product claim is that the instant product has to be a hydrate whereas the issued patent’s product does not have to be a hydrate.
Finding Prima Facie Obviousness
The X-ray diffraction peaks of the instant application have the same as the peaks claimed in the issued patent’s claims 9-14 and 21-27. Both crystalline forms have the same peaks and are prepared the same way according to the specification. Therefore, one of ordinary skill in the art would be motivated to prepare and claim both crystalline forms in the issued patent again in the instant application since majority of the peaks are the same. As a result, the claims are rejected under obviousness-type double patenting.
***closest prior art is Sasikumar, et al. (US 20150073024 A1) which does not teach specific crystalline hydrate forms or methods of using these form as claimed in the instant claimed application.
IV. Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Shawquia Jackson whose telephone number is 571-272-9043. The examiner can normally be reached on 7:00 AM-3:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Adam Milligan can be reached on 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/SHAWQUIA JACKSON/ Primary Examiner, Art Unit 1626
